BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 5041935 · Received August 31, 2015

    Report

    Report Number
    1818910-2015-29287
    Event Type
    Malfunction
    Date Received
    August 31, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 26, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED SIG FEM ADPT TORQUE WRENCH CONFIRMS THE BLACK CAP PROTECTOR IS BROKEN AND HAS DISASSEMBLED FROM THE WRENCH. CAPA (B)(4) WAS INITIATED TO FURTHER INVESTIGATE AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. (B)(4) HAS BEEN INITIATED TO CHANGE THE DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (B)(4). THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF (B)(4). NO FURTHER CORRECTIVE ACTION REQUIRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE PLASTIC COATING AROUND THE TORQUE WRENCH IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574414 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. SO2012912

    Patients

    Seq Age Sex Outcome Treatment
    1